[Data from Phase II studies of NKTR's inhaled aminoglycoside, which was partnered with Bayer last Aug, show high lung exposure with/without mechanical ventilation. Two phase III will being in Q4:08.]
FRANKFURT, May 20 (Reuters) - Bayer's (BAYG.DE: Quote, Profile, Research) experimental inhaler drug looked set to become a hit after a study of the device that patients use to inhale the antibiotic showed promising results, analysts said on Tuesday.
Deutsche Bank analysts said that the test results of drug-device combo Amikacin Inhale came as a surprise and that they expected the innovation could earn more than 200 million euros ($311 million).
Bayer and its partner, Nektar Therapeutics (NKTR.O: Quote, Profile, Research), are investigating the drug device for the treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients.
Gram-negative pneumonia, which is caused by a group of pathogens, accounts for a substantial proportion of pneumonia in intensive care units.
According to the Phase II study, Amikacin Inhale achieved over 1,000 times greater lung exposure to the antibiotic amikacin compared to injections.
"This shows that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication ... which may result in a higher likelihood of the patient's survival," the companies said late on Monday.
Currently, Gram-negative pneumonia kills one in two mechanically-ventilated patients.
Michael Niederman, chairman of the Department of Medicine at the Winthrop University Hospital in New York and one of the lead investigators of the study, said mechanically-ventilated patients in critical care were at high risk of pneumonia.
"Intravenous therapies cannot always reach effective concentrations in infected lungs at tolerable doses," he said.
"The new study data shows that the device successfully delivers the antibiotic directly to the site of infection, without reaching high systemic concentrations."
Amikacin Inhale combines a liquid formulation of the aminoglycoside antibiotic amikacin with Nektar's proprietary Liquid Pulmonary Technology, designed to deliver amikacin deep into the infected lungs.
The companies said enrolment for two late stage studies to further assess its effectiveness and safety will start in the fourth quarter of 2008.
NKTR Sells Pulmonary Business to Novartis for $115M
[The asset sale includes the permanent transfer of 140 employees from NKTR to NVS. This PR doesn’t say how many employees NKTR will have after the deal is consummated; NKTR laid off 150 in early 2008 (#msg-26740253). NKTR CC Tuesday at 10:30am ET.
NVS continues to leverage its balance sheet (#msg-32988098), although this is a very small deal by NVS’ standards.]
SAN CARLOS, Calif., Oct. 21 /PRNewswire-FirstCall/ -- (11:00 PM PT, Oct. 20) -- Nektar Therapeutics (Nasdaq: NKTR ) today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash.
“This agreement will allow us to focus our efforts on the development of novel therapeutics using our PEGylation and conjugate chemistry-based drug development platforms," said Nektar President and CEO Howard W. Robin. "The transaction also strengthens our balance sheet and significantly reduces expenses. It is a perfect example of our ability to monetize assets that had little future value for Nektar."
Novartis will assume ownership of certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility capital lease obligations. The agreement also transfers to Novartis approximately 140 Nektar personnel, as well as certain intellectual property and manufacturing methods. Additionally, Nektar will transfer manufacturing and royalty rights to the Tobramycin inhalation powder (TIP) program, already partnered with Novartis.
Nektar will retain ownership of its Bayer HealthCare-partnered program NKTR-061 (Amikacin Inhale), scheduled to enter Phase 3 clinical trials by year-end, and royalties to Ciprofloxacin inhaled powder (CIP), also partnered with Bayer HealthCare. Likewise, Nektar will retain NKTR-063 (inhaled vancomycin), a proprietary program scheduled to enter Phase 2 development in the U.S. early next year, as well as all intellectual property specific to inhaled insulin.
The transaction is subject to customary closing and regulatory conditions, including expiration of the 30-day waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Novartis and Nektar expect to complete the transaction on December 31, 2008. Nektar's financial guidance for 2008 will remain unchanged, excluding the positive effects of this transaction.
JPMorgan acted as exclusive financial advisor to Nektar.
Nektar to Host Investor Conference Call Tuesday October 21 at 7:30 AM Pacific time/10:30 AM Eastern to Discuss Novartis Transaction
Howard Robin, president and chief executive officer, will host a conference call Tuesday, October 21, 2008, beginning at 7:30 AM Pacific time/10:30 AM Eastern time. A live audio-only Webcast of the conference call can be accessed through a link that is posted on the Investor Relations section of the Nektar website: http://www.nektar.com. The web broadcast of the conference call will be available for replay through Tuesday, November 4, 2008.
To access the conference call by phone, follow these instructions: Dial: 866-713-8566 (U.S.); +1-617-597-5325 (international) Passcode: 44107011 (Howard Robin is the host)
An audio replay of the call will also be available shortly following the call through Tuesday, November 4, 2008 and can be accessed by dialing (888-286-8010) (U.S.); or 617-801-6888 (international) with a passcode of 50627256.
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and conjugate chemistry technology platforms. Nektar's technology and drug development expertise have enabled nine approved products for partners, which include leading biopharmaceutical companies. Nektar is also developing a robust pipeline of its own high-value therapeutics that addresses unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules.‹
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